Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.

NCT05539937 | Recruiting

• 1 other identifier: 2022-A00820-43
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In order to overcome the shortcomings of the assessment questionnaires currently available on the assessment of overall quality of life, the "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) was developed as a specific assessment tool for the impact of severe aortic stenosis in elderly patients, through 16 questions covering 5 domains: symptoms and physical limitations, emotional impact and expectations following TAVI, as well as social limitations incurred. A better knowledge and understanding of the clinical outcomes and quality of life of elderly patients with severe symptomatic aortic stenosis at 12 months of follow-up of a TAVI procedure would further optimize the clinical decision-making process and patient selection who will benefit the most from this intervention in the long term.

Conditions

Quality of Life; Aortic Valve Replacement; Transfemoral Approach

Outcome Measures

Primary Outcomes (1)

• Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI

  12 months

Study Arms (1)

Patient with percutaneous aortic valve replacement via the transfemoral approach

Other: Quality of life questionnaire

Interventions

Quality of life questionnaire OTHER

Before TAVI, 30 days, 6 months and twelve months after TAVI, patients will answer TASQ questionnaire,

Patient with percutaneous aortic valve replacement via the transfemoral approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who will have benefited of a transfemoral percutaneous aortic valve replacement; male or femal over 18 years of age.

You may qualify if:

• Male, female, over 18 years old,
• All patients who will have transfemoral percutaneous aortic valve replacement (TAVI) with implantation of a valve delivered on a balloon,
• Patient able to understand the study, and answer the TASQ questionnaire,
• Affiliation to a social security scheme or beneficiary of such a scheme,
• Patient having signed the free and informed consent.

You may not qualify if:

• Minor,
• Disorder of comprehension and/or expression,
• Patients unable to answer questions due to an underlying cognitive deficit or physical disability,
• Patients treated with a self-expanding valve,
• Refusal to participate in the study,
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
• Pregnant, parturient, or breast-feeding patient.

Sponsors & Collaborators

• Elsan: lead
• Belledonne clinic: collaborator
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Jean-François Oudet

La Rochette, 77000, France

RECRUITING

Central Study Contacts

Marie-Jeanne Bertrand, Dr

CONTACT

04 38 38 04 34; mariejeanne.bertrand@gmail.com

Jean-François Oudet

CONTACT

0683346567; jeanfrancois.oudet@free.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: March 21, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

FR (1)